Details for New Drug Application (NDA): 050617
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NDA 050617 describes ERYGEL, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the ERYGEL profile page.
The generic ingredient in ERYGEL is erythromycin. There are one hundred and three drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the erythromycin profile page.
The generic ingredient in ERYGEL is erythromycin. There are one hundred and three drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the erythromycin profile page.
Summary for 050617
| Tradename: | ERYGEL |
| Applicant: | Mylan |
| Ingredient: | erythromycin |
| Patents: | 0 |
Pharmacology for NDA: 050617
| Physiological Effect | Decreased Sebaceous Gland Activity |
Medical Subject Heading (MeSH) Categories for 050617
Suppliers and Packaging for NDA: 050617
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERYGEL | erythromycin | GEL;TOPICAL | 050617 | NDA | Mylan Pharmaceuticals Inc. | 0378-8075 | 0378-8075-60 | 1 TUBE in 1 CARTON (0378-8075-60) / 60 g in 1 TUBE |
| ERYGEL | erythromycin | GEL;TOPICAL | 050617 | NDA | Mylan Pharmaceuticals Inc. | 0378-8075 | 0378-8075-93 | 1 TUBE in 1 CARTON (0378-8075-93) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 2% | ||||
| Approval Date: | Oct 21, 1987 | TE: | AT | RLD: | Yes | ||||
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